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N O V E M B E R 2 0 0 3Members of theDermatological Drugs in PregnancyDivision of Dermatology
By MOHAMMED AL-HADDAB, MD, DENIS SASSEVILLE, MD, FRCPC
Three percent of all children born in the United States have a major structural malforma-tion that is detectable at birth1 and at least 10% of birth defects are thought to result frommaternal drug exposure.2 The approach of the medical community to using medication duringpregnancy has changed dramatically since the early 1960s, largely because of the epidemic ofphocomelia that followed the introduction of thalidomide and the late occurrence of vulvo-vaginal neoplasias in the female offspring of women who had received diethylstilbestrol dur-ing pregnancy. Since 1975, the U.S. Food and Drug Administration (FDA) has assignedpregnancy risk factors to all drugs used in the United States (Table 1). Unfortunately, manydrugs have not been adequately researched during pregnancy and, because of ethical consid-erations, probably will not be in the future.4While many drugs pose minimal risk during pregnancy and lactation, dermatologists areoften reluctant to prescribe any drugs during this period because many common dermatolog-ical conditions do not necessitate immediate therapy. Some patients are therefore deniedeffective treatment for their cutaneous condition because of excessive caution on the part oftheir physicians. On the other hand, when treating patients during pregnancy and lactation,dermatologists must be familiar with the potential effects that certain medications may haveon the developing fetus or the nursing infant. When a drug commonly used to treat a specificdermatological condition is potentially teratogenic, there are often alternatives that are saferto use in the pregnant or lactating patient.5After a brief summary of maternal pharmacokinetics and fetal development, this issue ofDermatology Rounds will review the safety of dermatological medications during pregnancy.The authors have decided on an approach by “disease” rather than by “drug” and challengethe reader to a quiz focusing on a series of clinical situations at the end of the article.Enjoy your reading!Centre universitaireMaternal pharmacokineticsde santé McGill
The 4 basic processes that govern the ultimate action of a drug are absorption, distribution,
McGill University
biotransformation, and excretion.6 The physiological changes that occur throughout pregnancy
Health Centre
may considerably alter these fundamental functions. High levels of progesterone in pregnancyare responsible for delayed gastric emptying, decreased gastrointestinal motility, and hyper-
McGill University Health Centre
emesis gravidarum. The normally rapid absorption of lipophilic drugs is not modified, but
hydrophilic, slowly transferred, and ionized drugs are more completely absorbed than in the
non-pregnant state and display a greater toxicity.7
The extracellular volume increases by up to 50% in the latter half of pregnancy, an expan-
sion that directly affects the distribution of most drugs. Thus, larger loading doses are usually
required to achieve similar plasma levels than during the nonpregnant state. Protein binding
decreases so that, at equilibrium, concentrations of pharmacologically-active free drugs may be higher.8
The editorial content of Dermatology
Hepatic blood flow is unmodified by pregnancy, but progesterone increases the activity of
Rounds is determined solely by the Division of Dermatology, McGill
hepatic microsomal enzymes, which causes faster inactivation of many drugs.7 Cardiac output
Table 1: FDA Pregnancy Drug Risk CategoriesTable 2: Teratogenic effects of syntheticretinoids
Positive evidence for risk to human fetus.Craniofacial
Risk cannot be ruled out. Animal studies
animal risk. Or: no risks in animal studies,
Controlled studies show no fetal risk.Central nervous systemUnrated: No pregnancy category has been assigned.
• Obstructive hydrocephalus• Non-obstructive hydrocephalus
and glomerular filtration rates increase by 30%-50%
during pregnancy. In the absence of toxemia and fluid
retention, drugs that are eliminated by the renal route
will clear more rapidly and have a shorter half-life.9
Cardiovascular systemFetal development
• Tetralogy of Fallot• Transposition of the great vessels
The implantation stage of fetal development extends
from day 1 to day 17 after conception. At this stage, all
cells are pluripotent and administration of toxic drugs tothe mother will result in abortion rather than in fetal
Skeletal system
malformations.The embryonic stage spans the second to
eighth week of pregnancy. Organogenesis occurs during
this critical period when teratogenic drugs are most like-
ly to exert their deleterious effects. The fetal stage coversthe period between the eighth week of pregnancy andparturition. Adverse effects of drugs given in this period
Psoriasis
include delayed somatic and psychomotor development,
Topical corticosteroids (category C) can generally be
as well as abnormal differentiation of genitalia. In the
utilized with relative safety during pregnancy since only
perinatal period, drugs may cause a variety of side effects
approximately 3% of the medication in topical prepara-
related to their pharmacologic activity, such as sedation,
tions is absorbed following 8 hours of contact with nor-
respiratory distress, hypotonia, jaundice, bleeding, etc.
mal skin.11 Calcipotriene (category C) is likewise safe forthe treatment of localized psoriasis during pregnancy, as
A review of dermatological agents and their effects
approximately 6% of the drug is absorbed systemically
during pregnancy
when the ointment is applied to psoriatic plaques.11
Acne
The general feeling about anthralin and tar is that
Isotretinoin is classified as category X and is well
these agents should be avoided during pregnancy.9 As
known for its teratogenic effects during pregnancy
PUVA is mutagenic and induces sister chromatid
(Table 2). Although tetracycline (category D) does not
exchange, it is considered a potential human teratogen.12
appear to be teratogenic when administered in the first
When this therapeutic modality is needed, topical
trimester, there is a risk of fatty liver atrophy in the
PUVA should be chosen. For patients with localized dis-
mother and deciduous dental staining in offspring when
ease of the palm and soles, topical PUVA does not give
administered later in gestation. Erythromycin (category
rise to detectable blood levels of 8-methoxypsoralen.13
B) is the agent of choice when a systemic antibiotic is
Ultraviolet B phototherapy is the safest treatment for
Topical therapy is the preferred method of treat-
Systemic corticosteroids in high doses have caused
ment for pregnant women with acne. Topical ery-
cleft palate in experimental animal models and low birth
thromycin (category B), clindamycin (category B) and
weight in humans.14 Placental 11-hydroxygenase meta-
benzoyl peroxide (category C) were recommended as
bolizes the short-acting agents prednisone, prednisolone,
the treatments of choice in a recent review.10 Topical
and methylprednisolone, and the fetus is exposed only to
metronidazole (category B) is another safe alternative.
approximately 10% of the maternal dose. There is no
Tretinoin (category C) has been considered as alternative
evidence that either prednisone or methylprednisolone
therapy in pregnancy.10 Tazarotene (category X) should
are teratogenic in humans.15,16 Acitretin (category X)
not be used in pregnant patients, although 6 women
and methotrexate (category X) are absolutely contra-
exposed to it during pregnancy had healthy babies.5
Pruritus and pruritic conditions
recent study suggests that mebendazole does not repre-
The first-generation H -antihistamines are consid-
sent a major teratogenic risk in humans when used in the
ered relatively safe in pregnancy. Promethazine and
doses recommended for pinworm (Enterobius vermicu-
hydroxyzine are category C, while chlorpheniramine,
laris) infestation.24 Thiabendazole (category C) has not
diphenhydramine, and cyproheptadine are category B.
been associated with adverse effects in human pregnancy,
Hydroxyzine is not thought to be associated with birth
but its safety is not clearly established. The newer alben-
defects.3,17 Among the second-generation H -antihista-
dazole has shown some teratogenicity in animals and its
mines, cetirizine and loratadine are the only two non-
use is contraindicated in pregnancy.
sedating agents in FDA category B, while fexofenadine iscategory C.5 The H -inhibitor cimetidine (category C)
Analgesics
has antiandrogenic effects when administered at high
Acetaminophen (category B) in therapeutic doses is
doses and carries the potential risk of feminization of a
safe for short-term use during all stages of pregnancy.
male fetus when given to a pregnant patient. Doxepin
Non-steroidal anti-inflammatory agents such as ibupro-
(unrated) should be avoided, especially close to the time
fen, ketoprofen, naproxen, and indomethacin are consid-
of delivery because it can induce ileus, cardiac dysryth-
ered to be FDA category B. However, when used in the
mias, irritability, and respiratory distress in the newborn.18
third trimester or near delivery, they are classified ascategory D because of the reported association with
Bacterial infections
oligohydramnios, prolonged labour, and premature clo-
Penicillins, cephalosporins, erythromycin, and azi-
sure of ductus arteriosus.5 These effects are secondary to
thromycin are all FDA category B and considered safe in
the inhibition of prostaglandin synthesis. A recent meta-
pregnancy. Sulfonamides are classified as category B for
analysis showed no evidence of an overall increase in
most of the gestation period, but are considered category
congenital malformation due to aspirin except for a
D when used near term because of the risk of hyper-
possible increased risk of gastroschisis when exposure
bilirubinemia and kernicterus. Quinolones (category C)
should be avoided in pregnancy because they have dele-terious effects on growing cartilage.3
Local anesthesia
There is no contraindication to the use of lidocaine
Fungal infections
(category B) with or without epinephrine (category B)
Topical antifungals are relatively safe in pregnancy.
during pregnancy for routine dermatological biopsies
Ketoconazole (category C) may cause sexual ambiguity
in the developing male fetus by inhibiting androgensynthesis.5 Itraconazole (category C) appears to be safe
Clinical situations
in pregnancy according to a recent prospective cohort
Case 1: A 42-year-old woman with dermatitis her-
study.19 The allylamine terbinafine (category B) is proba-
petiformis is treated and well-controlled with dapsone
bly even safer. Amphotericin B (category B) remains the
(avlosulfone) 100 mg orally per day. She has no children
drug of choice for systemic invasive mycotic infections,
and wants to become pregnant. What is your advice?
whether they are life-threatening or less severe.20
Case 2: A 37-year-old woman suffering from
Behcet’s disease and treated with colchicine presents to
Viral infections
the clinic with a positive pregnancy test. Based on the
Trichloroacetic acid and physical modalities such as
date of her last menstrual period, you estimate a gesta-
cryotherapy, electrodesiccation, and laser vaporization
tional age of 7 weeks. Will you recommend an amnio-
are effective alternatives that are thought to be safer
during pregnancy than imiquimod (category B) and
Case 3: A 25-year-old woman has discoid lupus
podophyllin (category C) for the treatment of genital
erythematosus of the scalp, well controlled with oral
warts.9,21 Five hundred and fifty-two women exposed to
hydroxychloroquine. She comes to your office in tears,
acyclovir (category C) during the first trimester of preg-
saying, “Doctor, I am 14 weeks pregnant and I stopped
nancy demonstrated no increased rate of birth defects.22
taking the medication 3 weeks ago. I want to keep my
Published information is scanty on the newer antivirals
child, but I don’t want to lose my hair, what am I sup-
such as famciclovir (category B) and valacyclovir (cate-
Case 4: A 32-year-old primigravida, in her 26th
week of pregnancy, comes to the emergency room with
Parasitic infestations
fever and a generalized pustular eruption of sudden
Permethrin (category B) and precipitated sulfur are
onset, consistent with pustular psoriasis or impetigo her-
considered safe during pregnancy. Ivermectin (category
C) is teratogenic in animals at high doses and should be
Case 5: A 30-year-old woman, known for recurrent,
avoided during pregnancy pending further studies.23 A
moderately severe erythema multiforme, on suppressive
acyclovir therapy, is planning to get pregnant in the
pregnant patients with cutaneous involvement only,
near future. She wants to know if acyclovir can
the risks probably outweigh the benefits. Other
cause potential fetal adverse effects. What are her
therapeutic modalities, such as potent topical or
intralesional corticosteroids, should be considered as
Case 6: A 29-year-old Vietnamese woman, a
newly landed immigrant, is 11 weeks pregnant and
Case 4: Fulminating generalized pustular psori-
presents to the dermatology clinic with a skin lesion
asis in pregnancy is best treated with prednisolone,
on the dorsum of her right hand that has slowly
the drug that carries the least hazard for the fetus.28
been enlarging over a few months. A skin biopsy
In a 4- to 5-year follow-up of children whose moth-
confirms the diagnosis of tuberculosis verrucosa
ers had received cyclosporin-A (category C) during
cutis. How should this patient be treated?
pregnancy, no structural malformations or signifi-
Case 7: A 27-year-old woman in her 18th week
cant learning disabilities were noted.29 Several stud-
of pregnancy presents with severe candidal vaginitis
ies have reported no problems in infants whose
and intertrigo not responding well to topical antifun-
mother or father had been treated with oral 8-
gals. Can you safely treat her with a systemic agent?
methoxypsoralen (category C) and UVA in the
Case 8: A 38-year-old healthy woman comes to
preconceptional period or during early pregnancy.
the clinic with her 47-year-old husband who is on
However, these studies were small. It has been sug-
methotrexate for psoriasis and psoriatic arthritis.
gested that women who become pregnant during or
They are planning to have a baby and ask you if
after PUVA treatment should be offered prenatal
methotrexate will adversely affect their future child
karyotyping to rule-out the possibility of chromoso-
Case 9: A 20-year-old woman, with moderatelyCase 5: Acyclovir (category C) is not terato-
severe atopic dermatitis that is well-controlled by
genic in animals, but it causes fetal death, growth
topical tacrolimus, wants to become pregnant. She
retardation, and malformations in rats at mater-
asks if it is safe to continue the medication during
notoxic doses. Use in human pregnancies has not
been associated with adverse fetal effects. Briggsstates that there are insufficient available data to
Answers to the clinical situations
establish the safety of this medication and that its
Case 1: Briggs states that the use of dapsone
use for recurrent herpes simplex infection is not a
(category C) during pregnancy poses no major risk
convincing indication.18 In pregnancy, acyclovir should
to the fetus. Numerous women have conceived nor-
be restricted to severe infections. In cases of recur-
mal offspring while receiving dapsone for leprosy.
rent, widespread, and incapacitating erythema mul-
Stopping therapy during the last month of pregnancy
tiforme, the use of acyclovir is probably justified.
may minimize a theoretical risk of neonatal
Case 6: Isoniazid, rifampin, ethambutol, and
pyrazinamide have an excellent safety record in
Case 2: The children of 116 women taking
pregnancy and are not associated with human fetal
colchicine (category D) for familial Mediterranean
malformation. Streptomycin should not be used
fever were followed. Among 225 completed preg-
since 1 in 6 infants will have hearing loss and
nancies, an unusual frequency of fetal abnormalities
vestibular problems. Tuberculin testing is safe, while
could not be found. Colchicine therapy during
BCG vaccine should be avoided in pregnancy.
pregnancy does not apparently harm mother or
Among the second-line agents used for treating
drug-resistant tuberculosis, ciprofloxacin (category
Case 3: Both chloroquine and hydroxychloro-
C) has the best safety profile, despite its potential
quine (unrated) accumulate in the fetal eye and are
retained in ocular tissue for at least 5 months. The
Case 7: Fluconazole (category C) in high doses
terminal half-life of hydroxychloroqine is 1 to 2
has been associated with human malformations.18
months.18 Cases of fetal retinal degeneration and
First trimester exposure to low doses of fluconazole
severe cochleo-vestibular dysfunction have been
does not appear to increase the prevalence of mis-
recorded, but other authors have not found a
carriages, congenital anomalies, or low birth weight.31
greater risk of malformation. Some argue that the
Case 8: Both males and females should avoid
risk of an exacerbation of collagen vascular disease
methotrexate if pregnancy is anticipated, at least
also puts the fetus at risk and that continuation of
3 months for males, and 1 menstrual period for
antimalarials during pregnancy should be seriously
considered.27 This course of action appears to be
Case 9: In a recent study, after topical applica-
justified in systemic lupus erythematosus, but in
tion, tacrolimus (category C) was undetectable in
Table 3: A summary of FDA Pregnancy and Lactation Categories for some systemic and topical medications (Refer to Table 1 for meaning of letter designation).AntibioticsParasiticidesAntihistaminesAnalgesicsMiscellaneousLocal anestheticsAntifungalsAntineoplastic/ImmunosuppressantsAntivirals
80% of collected blood samples. In the other 20%,
4. Black RA, Hill A. Over-the-Counter medications in pregnancy.Am Fam Physician 2003;67(12):2517-2524.
measurable levels of tacrolimus were transitory and
5. Hale EK, Keltz Pomeranz M. Dermatological agents during
not associated with adverse events.33 The drug
pregnancy and lactation. An update and clinical review. Int J
appears reasonably safe for topical use during preg-
nancy except for widespread application to areas
6. Juchau MR Faustman-Watts E. Pharmacokinetic considera-
tions in the maternal-placental-fetal unit. Clin Obstet Gynecol
where the integrity of the cutaneous barrier is signi-
ficantly compromised (eg, Netherton Syndrome).11,34
7. Livezey GT, Rayburn WF. Principles of perinatal pharmacolo-
gy. In: Rayburn WF, Zuspan FP, eds. Drug Therapy in Obstetricsand Gynecology. 3rd ed. St.Louis: Mosby-Year Book;992:3-11.Conclusion
8. Cupit GC,.Rotmensch HH. Principles of drug therapy. In:
While it is most prudent to avoid all medica-
Gleicher N, ed. Principles of Medical Therapy in Pregnancy.2nd ed. Norwalk, CT: Appleton & Lange;1992:68-79.
tions during pregnancy, treatment frequently
9. Sasseville D. Dermatological therapy during pregnancy and
cannot be delayed. It is the duty of the physician to
lactation. In: Harahap M, C.Wallach RC, eds. Skin Changes
understand the potential risk of the drugs that he
and Diseases in Pregnancy. NewYork: Marcel Dekker;1996:249-319.
routinely prescribes (Table 3). The pregnant patient
10. Koren G, Pastuszak A, Itu S. Drugs in pregnancy. N Engl J Med
ultimately needs to decide if she wants to expose
her fetus to a systemic drug. An informed decision
11. Tausher AE, Fleischer AB Jr., Phelps KC, Feldman SR. Psoria-
sis and pregnancy. J Cutan Med Surg 2002;6:561-570.
about whether or not to treat a woman during
12. Stern R S, Lange R. Outcome of pregnancies among women
pregnancy should be based on the potential risks of
and partners of men with a history of exposure to PUVA for
the drug versus the degree to which the condition
the treatment of psoriasis. Arch Dermatol 1991;127:347-350.
13. Pham C T, Kuo J Y. Plasma levels of 8-Methoxypsoralen after
affects the woman’s health and well-being.
topical paint PUVA. J Am Acad Dermatol 1993;28:460-466.
14. Pirson Y, Van Lierda M, Ghysen J, et al. Retardation of fetal
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6-11 February 200462nd Annual Meeting of the Abstracts of InterestAmerican Academy of DermatologyDrug administration for the pregnant or lactating woman:A reference guide for dermatologists.
Dermatologists are occasionally faced with the problem of appro-priate systemic drug administration to the lactating or pregnantwoman. The physician’s responsibility is to be aware of the potential
Change of address notices and requests for subscriptions
risk of prescribing a specific therapeutic agent, to inform the mother
for Dermatology Rounds are to be sent by mail to P.O. Box
of this risk, and to administer an alternate, less deleterious drug, if
310, Station H, Montreal, Quebec H3G 2K8 or by fax to
available. The purpose of this review is to provide guidelines for
(514) 932-5114 or by e-mail to [email protected]
dermatologists who must consider the risk to the fetus or neonate of
Please reference Dermatology Rounds in your correspondence.
drug administration to the pregnant woman or lactating mother.
Undeliverable copies are to be sent to the address above.J Am Acad Dermatol 1990;23:87-103.
This publication is made possible by an educational grant from
Novartis Pharmaceuticals Canada Inc.
2003 Division of Dermatology, McGill University Health Centre, Montreal, which is solely responsible for the contents. The opinions expressed in this publication do notnecessarily reflect those of the publisher or sponsor, but rather are those of the authoring institution based on the available scientific literature. Publisher: SNELL MedicalCommunication Inc. in cooperation with the Division of Dermatology, McGill University Health Centre. ™Dermatology Rounds is a Trade Mark of SNELL Medical CommunicationInc. All rights reserved. The administration of any therapies discussed or referred to in Dermatology Rounds should always be consistent with the recognized prescribing informationin Canada. SNELL Medical Communication Inc. is committed to the development of superior Continuing Medical Education.

Presentation by Marcel Brasey (Geneva/Switzerland) at Congress “The Alzheimer’s disease: a social challenge” on June 5, 2009 in Paris/France ( Translated from French by Mitchell Slutzky ) Ladies and gentlemen, Hello! My name is Marcel Brasey. I am 65 years old and I am Swiss-German. For the past 10 years, I have lived with the diagnosis of probable dementia of the Alzheimer’s